BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 2466794 · Received February 17, 2012

    Report

    Report Number
    2020362-2012-00086
    Event Type
    Malfunction
    Date Received
    February 17, 2012
    Report Date
    January 20, 2012
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL AND HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM WILL NOT RELEASE FROM THE HOLD MODE ONCE WEIGHT IS RETURNED TO THE SENSOR. THE BATTERIES WERE REPLACED WITH A NEW SUPPLY. NO VISIBLE DAMAGE WAS OBSERVED TO THE OUTSIDE OF THE ALARM. THE ISSUE WAS FOUND DURING SETUP. THERE WAS NO PT CONTACT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY KEEPSAFE DELUXE KMI J. T. POSEY CO. 8374 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA SQUARE CHAIR SENSOR PAD: MODEL # 8308, LOT # UNK